BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Cana

FDA device recall Z-1135-2008 · posted 2008-02-26 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.

Action taken

Arjo sent Urgent Device Field Correction Notification letters dated 12/19/07 to the end user accounts who received the affected scales, advising them of the potential for the hanger bar assembly to detach. The accounts were given the option immediately stopping use of the lifts with the affected scales or removing the scales from the lift so the lift can continue to be used. Instructions for removal of the scales were provided with the letter. The accounts were requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter, and indicating whether they will complete the correction upon receipt of the correction parts or if they require the assistance of an Arjo Service Technician.

Root cause

Device Design

Status

Terminated

Product code

FRW

Quantity affected

772 scales

Distribution

Nationwide including the states of Alabama, Arizona, California, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New

Date initiated

2007-12-19

Date posted

2008-02-26

Date terminated

2009-11-18

Location

Roselle, IL